Fukuda Denshi Vasera Model VS-1500
FDA 510(k) K112521 · Fukuda Denshi USA, Inc.
510(k) numberK112521
Submission
- Device name
- Fukuda Denshi Vasera Model VS-1500
- Applicant
- Fukuda Denshi USA, Inc.
Redmond, WA, US - Received
- August 31, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
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| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
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| K103134 | Fukuda DenshiMHX · Traditional | 03/11/2011SE |
| K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…MHX · Traditional | 03/19/2009SE |
| K082656 | Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitIYN · Traditional | 09/30/2008SE |
| K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorMHX · Traditional | 08/29/2008SE |
| K050363 | Fukuda Denshi Model UF-850XTDIYN · Special | 02/17/2005SE |
| K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemMHX · Special | 06/03/2004SE |
| K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorMHX · Traditional | 05/26/2004SE |
Questions and answers
When was Fukuda Denshi Vasera Model VS-1500 cleared by the FDA?
Fukuda Denshi Vasera Model VS-1500 (K112521) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 112 days after the submission was received.
What is the product code of K112521?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.